Status:
COMPLETED
Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Lead Sponsor:
Bayer
Collaborating Sponsors:
Orion Corporation, Orion Pharma
Conditions:
Prostate Cancer Non-Metastatic
Castration-Resistant
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
- Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.
- Prostate-specific Antigen (PSA) doubling time of ≤ 10 months and PSA \> 2ng/ml.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl.
- Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.
- Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.
Exclusion
- History of metastatic disease at any time or presence of detectable metastases.
- Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
- Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor.
- Use of estrogens or 5-α reductase inhibitors or AR inhibitors.
- Prior chemotherapy or immunotherapy for prostate cancer.
- Use of systemic corticosteroid.
- Radiation therapy within 12 weeks before randomisation.
- Severe or uncontrolled concurrent disease, infection or co-morbidity.
- Treatment with bisphosphonate or denosumab within 12 weeks before randomisation.
- Known hypersensitivity to the study treatment or any of its ingredients.
- Major surgery within 28 days before randomisation.
- Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
- Uncontrolled hypertension.
- Prior malignancy.
- Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
- Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
- Treatment with any investigational drug within 28 days before randomisation.
- Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.
Key Trial Info
Start Date :
September 12 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2021
Estimated Enrollment :
1509 Patients enrolled
Trial Details
Trial ID
NCT02200614
Start Date
September 12 2014
End Date
June 14 2021
Last Update
June 28 2022
Active Locations (404)
Enter a location and click search to find clinical trials sorted by distance.
1
Homewood, Alabama, United States, 35209
2
Anchorage, Alaska, United States, 99503
3
Tucson, Arizona, United States, 85704
4
Fountain Valley, California, United States, 92708